Hospital Management
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Centralized Utilization Review: Key Considerations for Successful Implementation
As hospitals grapple with ever-changing utilization review (UR) guidelines from CMS and consolidate with other facilities, many are centralizing their UR operations. Under a centralized model, an offsite UR nurse or case manager is alerted when a new patient is admitted and sees all the documentation necessary to determine whether the medical record supports the patient’s status. Centralized UR establishes a standardized common process across facilities, which is a key benefit for multihospital health systems.
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CMS Update: Outpatient Total Knee, Hip Arthroplasty
To provide patients with better value and results, CMS has issued a final rule regarding the inpatient-only list of surgical procedures. This list includes procedures that typically are only provided in the inpatient setting and not paid under the Outpatient Prospective Payment System. Criteria for removing procedure from the inpatient-only list includes determining that the procedure is performed in numerous hospitals on an outpatient basis. For example, total knee arthroplasty moved from the list starting in 2018. Total hip arthroplasty is expected to be removed from the list in 2020.
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CMS 2020 Final Rules: Infection Control in Inpatient and Long-Term Acute Care
Antimicrobial resistance represents a serious risk for Medicare beneficiaries and for the public overall. CMS is finalizing an alternative new technology add-on payment pathway for antimicrobial products designated by the FDA as Qualified Infectious Disease Products (QIDPs). Under this policy, a QIDP will be considered new and will not need to demonstrate that it meets the substantial clinical improvement criterion; it will only need to meet the cost criterion. CMS also is increasing the new technology add-on payment to 75% for an antimicrobial designated as a QIDP.
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CMS Issues 2020 Final Rules for Inpatient and Long-Term Acute Care
The Centers for Medicare & Medicaid Services issued its final rule in August to update the Medicare payment policies for hospitals under the Inpatient Prospective Payment System and the Long-Term Care Hospital Prospective Payment System for fiscal year 2020. Changes were made to the rural hospital wage index, all-cause readmissions, and interoperability.
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Tips for Including Plain Language in Informed Consent Form
Many informed consent forms fail to communicate simply and clearly. They might use language prospective research participants may not process easily. While the new Common Rule provides some suggestions for making informed consent documents more readable, there are additional steps IRBs and researchers could take to improve the forms, including incorporating plain language.
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Sample Models of Post-Approval Monitoring Programs
There are many ways IRBs could conduct post-approval monitoring programs. These can range from simple email questions and answers to full reviews at the research site. These programs often are designed to be educational, as well as adding a layer of accountability in the human research protection process.
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In New Common Rule Era, There Is Role for Post-Approval Monitoring
Post-approval monitoring (PAM) is one method that IRBs could employ when keeping tabs on minimal-risk studies or studies that no longer have to go through the continuing review process. It also can be a way for a small IRB to improve office efficiency and enhance relationships with investigators. IRBs that would like additional information from studies, after continuing review ends, could use PAM to obtain that information.
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‘Re-Consent’ a Gray Area for IRBs
Wading into a thicket of ethical and legal issues, SACHRP is trying to clarify the concept of “re-consent” and when is it necessary.
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SACHRP Approves Participant Payment Guidelines
The Secretary’s Advisory Committee on Human Research Protections (SACHRP) recently approved guidelines on paying research participants, addressing a range of issues from “token” payments to frank coercion. After considerable discussion into the ethical implications of paying subjects too much or too little, SACHRP approved the guidelines, entitled “Addressing Ethical Concerns Regarding Offers of Payment to Research Participants.”
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Physician Not Liable for Alleged Complications After Gallbladder Removal
This successful defense case reveals potent methods for defeating medical malpractice claims. On the substance, the defendant physician successfully challenged one of the necessary elements that an injured patient must prove when alleging medical malpractice: causation. Causation includes factual and legal aspects, where the physician’s actions must have been a “substantial factor” in contributing to the patient’s harm, but there may be an intervening action or event that cuts off the physician’s liability. If the risk of injury exists, even when a procedure is performed correctly, then simply because an injury occurred does not mean that the physician was negligent.